Exploring the current use and future of alternatives to traditional informed consent in acute stroke trials
MSN highlighted an editorial written by the University of Cincinnati’s Yasmin Aziz, MD, and Joseph Broderick, MD, published Nov. 7 in the journal Neurology analyzing the current use and potential future of alternatives to traditional informed consent in acute stroke trials.
Patient informed consent is a crucial part of ethical clinical trial design and implementation, but time is of the essence for stroke trials. Approximately 2 million neurons die each minute they are deprived of oxygen, and patients are also sometimes incapacitated and therefore unable to consent to a trial, highlighting the need for emergency consent in certain cases.
There is currently no worldwide standard for emergency consent for stroke trials, with various approaches taken by different countries.
“This editorial is intended to educate the greater neurology community about these consent procedures and their current relevance to stroke research in particular,” said Aziz, assistant professor in the Department of Neurology and Rehabilitation Medicine in UC’s College of Medicine and a UC Health physician.
Broderick is principal investigator of the FASTEST trial, the first acute stroke trial in the United States to use exception from informed consent (EFIC) protocols.
“...Community consultation and public disclosure are unique to EFIC,” the authors wrote. “Both requirements can be quite expensive and time-consuming, delaying study start-up. Efforts to make EFIC more efficient and less costly in the US are ongoing.”
The coauthors noted as the field continues to explore the most effective and efficient alternatives to prospective informed consent, the “principles of patient autonomy and beneficence remain imperative.” Aziz said improving consent procedures is an opportunity to “keep moving the chains forward” for stroke research.
“The United States in particular has a very dark, very recent, unethical history with certain populations and the performance of clinical research,” she said. “We need to find the best way to honor patient autonomy while moving research forward to ultimately get better treatments to the bedside.”
Neuro Rehab Times also covered the editorial. Read the Neuro Rehab Times article.
Featured photo at top of brain scans. Photo courtesy of Joseph Broderick.
Latest UC News
- Poll shows grandkids help grandparents feel less lonelyThe role of a grandparent is multifaceted and valuable, especially when families are facing a childcare crisis or when someone needs to fill the "parent" role for unforeseen reasons. Despite some of the immediate impact that grandparents have on grandkids, new data suggests the benefits flow both ways. A recent poll conducted by the University of Michigan shows the importance of grandchildren in grandparents' lives.
- Exploring the differences between men and women with traumatic brain injuriesThe University of Cincinnati's Brandon Foreman joined a panel discussion on WVXU's Cincinnati Edition discussing current knowledge and the need for further research into the differences between. men and women experiencing traumatic brain injuries.
- Sale-leaseback transaction contributes to Frisch’s closingsThe Frisch’s Big Boy chain could be forced to close more restaurants, which can in part be traced back to the sale-leaseback transaction by the company, University of Cincinnati Real Estate Center Executive Director Carl Goertemoeller told WCPO.
- Wrongful conviction: ‘I lost my mother and father while in prison’Robert McClendon, an Ohio Innocence Project exoneree, speaks with WYSO about wrongful conviction.
- New effort aims to keep unsold clothing donations out of the landfillWVXU hosts leadership from Ohio Valley Goodwill Industries and UC fashion design student Wesley Beisel to speak to how donated items contribute to sustainable living. Beisel is the student lead of the Sustainable Fashion Initiative (SSI) which originated at UC.
- Hamilton County Job & Family Services grows toy drive for kids in foster careHamilton County’s goal to give all kids in foster care at least two gifts this year is drawing unprecedented support from high-profile community organizations, including Hoxworth Blood Center and the Bengals. Donate a toy at any of the seven Hoxworth neighborhood donor centers from November 17-23, 2024.
